[House Report 113-683]
[From the U.S. Government Publishing Office]


113th Congress   }                                       {       Report
                        HOUSE OF REPRESENTATIVES
 2d Session      }                                       {      113-683

======================================================================

 
 TO REQUIRE THE SECRETARY OF HEALTH AND HUMAN SERVICES TO PROVIDE FOR 
RECOMMENDATIONS FOR THE DEVELOPMENT AND USE OF CLINICAL DATA REGISTRIES 
                  FOR THE IMPROVEMENT OF PATIENT CARE

                                _______
                                

 December 22, 2014.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

         Mr. Upton, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 5214]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5214) to require the Secretary of Health and 
Human Services to provide for recommendations for the 
development of patient care, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     3
Hearings.........................................................     3
Committee Consideration..........................................     4
Committee Votes..................................................     4
Committee Oversight Findings.....................................     5
Statement of General Performance Goals and Objectives............     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     5
Committee Cost Estimate..........................................     5
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................     6
Duplication of Federal Programs..................................     6
Disclosure of Directed Rule Makings..............................     6
Advisory Committee Statement.....................................     6
Applicability to Legislative Branch..............................     6
Section-by-Section Analysis of the Legislation...................     6
Changes in Existing Law Made by the Bill, as Reported............     7
    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. RECOMMENDATIONS FOR DEVELOPMENT AND USE OF CLINICAL DATA 
                    REGISTRIES.

  (a) In General.--Not later than one year after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
make recommendations for the development and use, when appropriate, of 
clinical data registries that are integrated with clinical practice 
guidelines and best practices or standards of care, including 
recommendations designed to minimize duplication and burden on those 
operating or reporting to such registries, for the improvement of 
patient care. The Secretary shall make such recommendations available 
to the public by posting them on a public Website of the Department of 
Health and Human Services.
  (b) Specific Recommendations.--Such recommendations, with respect to 
such registries, shall include the following:
          (1) Recommendations for a set of standards that, if adopted 
        by such registries, would allow for the bidirectional, 
        interoperable exchange of information between the electronic 
        health records of the reporting clinicians and such registries.
          (2) Recommendations on how clinical registries, including 
        outcomes-based registries, may be developed and then used to 
        evaluate various care models and methods, including improved 
        clinical care coordination, and the impact of such models and 
        methods on the management of diseases as measured by 
        appropriate care parameters based on clinical practice 
        guidelines and best practices (such as A1C, blood pressure, and 
        cholesterol levels in the case of diabetes).
          (3) Recommendations on how such registries should be 
        structured to facilitate--
                  (A) the recording and reporting of post-market data 
                for the purposes of monitoring safety and efficacy of 
                FDA-approved devices and drugs;
                  (B) the reporting of relevant clinical data to 
                satisfy attestation requirements for coverage of 
                prescribed devices; and
                  (C) coverage with evidence development policies for 
                devices under the Medicare program (such as improving 
                patient access to safe and effective glucose monitoring 
                systems).
          (4) Recommendations on how data from such registries may be 
        used to inform physicians and other health care professionals 
        regarding clinical practices for the prevention of diseases 
        (such as diabetes and the precursor conditions of diabetes) and 
        appropriate methods for the dissemination of clinical practice 
        support tools and other educational resources that may be 
        derived from registry data.
          (5) Recommendations for how registries can be used to promote 
        preventive health benefits such as screenings and the Medicare 
        annual wellness visits that may reduce the risk of chronic 
        diseases (such as obesity, osteoporosis, cardiovascular 
        disease, cancer, diabetes and their complications).
  (c) Consultation With Clinical Experts.--The Secretary shall consult 
with national medical specialty societies, patient groups, technology 
vendors, and developers and manufacturers of drugs and medical devices 
in the development of such recommendations as they relate to the 
diseases that members of such societies manage and treat (such as with 
endocrinologists with respect to recommendations relating to diabetes 
and pre-diabetes conditions).
  (d) Rule of Construction.--Nothing in this section may be construed 
as--
          (1) authorizing the Secretary of Health and Human Services to 
        take any action with regard to the recommendations made under 
        this section (other than making such recommendations available 
        to the public in the manner described in subsection (a));
          (2) limiting or interfering with the authority of a health 
        care practitioner to practice medicine or to prescribe or 
        administer a drug or device to an individual for a condition or 
        disease; or
          (3) providing the Centers for Medicare & Medicaid Services 
        with authority to limit (or to encourage other individuals or 
        entities to limit) coverage under the Medicare program under 
        title XVIII of the Social Security Act for an item or service 
        furnished to an individual on account of the participation, or 
        lack of participation, of the individual in a registry or other 
        data collection system.

                          PURPOSE AND SUMMARY

    H.R. 5214, a bill to streamline government recommendations 
related to the development of clinical data registries, was 
introduced on July 28, 2014, by Representative Pete Olson (R-
TX) and subsequently referred to the Committee on Energy and 
Commerce.
    The legislation would require the Secretary of Health and 
Human Services (HHS) to provide for recommendations for the 
development and use of clinical data registries that are 
integrated with clinical practice guidelines and best practices 
or standards of care.

                  BACKGROUND AND NEED FOR LEGISLATION

    Clinical data registries present opportunities for the 
collection and dissemination of clinical data that can be used 
to improve the quality of care delivered, increase research and 
surveillance opportunities for treatments and services, and 
ease the burden of government and other payer requirements on 
developers and providers.
    Many sub-agencies within HHS have rules that relate to the 
ways in which data registries can be used to facilitate 
reporting and other administrative requirements. Qualified 
clinical data registries (QCDR) are just one example and were 
included as an authorized reporting mechanism available for the 
Physician Quality Reporting System (PQRS) under the Medicare 
Physician Fee Schedule beginning in 2014.\1\ A QCDR is a 
Centers for Medicare and Medicaid Services (CMS)-approved 
entity that collects medical and/or clinical data for the 
purpose of patient and disease tracking to foster improvement 
in the quality of care provided to patients.
---------------------------------------------------------------------------
    \1\CMS, Physician Quality Reporting System www.cms.gov.
---------------------------------------------------------------------------
    Unfortunately, these various sub-agencies do not always use 
the same requirements related to the collection, dissemination, 
and administration of registry data. Various payment rules and 
agency publications oftentimes can offer contradictory 
statements that needlessly increase the burden on those seeking 
to operate and employ registries. The Committee believes such 
duplication in many instances is unnecessary.
    The legislation would seek to engage the Secretary in a 
process of disseminating information on a set of 
recommendations related to the form and function of registries. 
Such a process would force HHS and its sub-agencies to rethink 
the current piece-meal approach to registry requirements and 
facilitate greater transparency for policymakers to ensure 
government requirements are streamlined and efficient.
    The Committee recognizes, however, that registries have 
various users, audiences, and purposes (as is evidenced by the 
multi-stake-holder developed Agency for Healthcare Research and 
Quality User Guide and the American Medical Association's 
National Quality Registry Network process). The Committee does 
not intend for this new requirement in the legislation to limit 
flexibility or stymie development of registries by forcing 
current innovation into a one-size-fits all registry approach. 
The Committee expects the Secretary will work to improve 
coordination without sacrificing innovation.

                                HEARINGS

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        COMMITTEE CONSIDERATION

    On July 29 and 30, 2014, the full Committee met in open 
markup session and approved H.R. 5214, as amended, by a record 
vote of 25 yeas and 18 nays.

                            COMMITTEE VOTES

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Upton to order H.R. 5214, reported to the House, 
as amended, by a record vote of 25 yeas and 18 nays. The 
following reflects the record votes taken during the Committee 
consideration:

            COMMITTEE ON ENERGY AND COMMERCE--113TH CONGRESS

                           ROLL CALL VOTE #47

Bill: H.R. 5214, a bill to require the Secretary of Health and Human 
        Services to provide for recommendations for the development and 
        use of clinical data registries for the improvement of patient 
        care

    Amendment: A motion by Mr. Upton to order H.R. 5214 
favorably reported to the House, as amended. (Final Passage), 
Disposition: Agreed to, by a roll call vote of 25 yeas and 18 
nays

----------------------------------------------------------------------------------------------------------------
         REPRESENTATIVE            YEAS      NAYS     PRESENT     REPRESENTATIVE     YEAS      NAYS     PRESENT
----------------------------------------------------------------------------------------------------------------
Mr. Upton......................        X   ........  .........  Mr. Waxman.......  ........        X   .........
Mr. Hall.......................        X   ........  .........  Mr. Dingell......  ........  ........  .........
Mr. Barton.....................        X   ........  .........  Mr. Pallone......  ........        X   .........
Mr. Whitfield..................  ........  ........  .........  Mr. Rush.........  ........  ........  .........
Mr. Shimkus....................        X   ........  .........  Ms. Eshoo........  ........        X   .........
Mr. Pitts......................        X   ........  .........  Mr. Engel........  ........        X   .........
Mr. Walden.....................        X   ........  .........  Mr. Green........  ........        X   .........
Mr. Terry......................        X   ........  .........  Ms. DeGette......  ........        X   .........
Mr. Rogers.....................  ........  ........  .........  Mrs. Capps.......  ........        X   .........
Mr. Murphy.....................        X   ........  .........  Mr. Doyle........  ........        X   .........
Mr. Burgess....................        X   ........  .........  Ms. Schakowsky...  ........  ........  .........
Mrs. Blackburn.................        X   ........  .........  Mr. Matheson.....  ........        X   .........
Mr. Gingrey....................        X   ........  .........  Mr. Butterfield..  ........        X   .........
Mr. Scalise....................  ........  ........  .........  Mr. Barrow.......  ........        X   .........
Mr. Latta......................        X   ........  .........  Ms. Matsui.......  ........  ........  .........
Mrs. McMorris Rodgers..........  ........  ........  .........  Ms. Christensen..  ........  ........  .........
Mr. Harper.....................        X   ........  .........  Ms. Castor.......  ........        X   .........
Mr. Lance......................        X   ........  .........  Mr. Sarbanes.....  ........        X   .........
Mr. Cassidy....................        X   ........  .........  Mr. McNerney.....  ........        X   .........
Mr. Guthrie....................        X   ........  .........  Mr. Braley.......        X   ........  .........
Mr. Olson......................        X   ........  .........  Mr. Welch........  ........        X   .........
Mr. McKinley...................        X   ........  .........  Mr. Lujan........  ........        X   .........
Mr. Gardner....................        X   ........  .........  Mr. Tonko........  ........        X   .........
Mr. Pompeo.....................  ........  ........  .........  Mr. Yarmuth......  ........        X   .........
Mr. Kinzinger..................        X   ........  .........
Mr. Griffith...................        X   ........  .........
Mr. Bilirakis..................        X   ........  .........
Mr. Johnson....................        X   ........  .........
Mr. Long.......................        X   ........  .........
Mrs. Ellmers...................  ........  ........  .........
----------------------------------------------------------------------------------------------------------------

                      COMMITTEE OVERSIGHT FINDINGS

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

    The goal of the legislation is to streamline the various 
governmental reporting requirements related to clinical data 
registries for the purpose of supporting registry development 
and use by requiring the Secretary to publish one set of 
recommendations.

   NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
5214 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       EARMARK, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the House of Representatives, the Committee finds that H.R. 
5214 contains no earmarks, limited tax benefits, or limited 
tariff benefits.

                        COMMITTEE COST ESTIMATE

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  CONGRESSIONAL BUDGET OFFICE ESTIMATE

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                Washington, DC, September 10, 2014.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Chairman: The Congressional Budget Office has prepared 
the enclosed cost estimate for H.R. 5214, a bill to require the 
Secretary of Health and Human Services to provide for 
recommendations for the development and use of clinical data 
registries for the improvement of patient care.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Amber G. 
Marcellino.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 5214--A bill to require the Secretary of Health and Human Services 
        to provide for recommendations for the development and use of 
        clinical data registries for the improvement of patient care

    H.R. 5214 would require the Secretary of Health and Human 
Services to make recommendations for the development and use of 
clinical data registries for the improvement of patient care. 
The legislation would direct the Secretary to post such 
recommendations on the agency's website.
    CBO estimates that implementing the bill would have no 
significant effect on spending subject to appropriation. 
Enacting H.R. 5214 would not affect direct spending or 
revenues; therefore, pay-as-you-go procedures do not apply.
    H.R. 5214 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would not affect the budget of state, local, or tribal 
governments.
    The CBO staff contact for this estimate is Amber G. 
Marcellino. The estimate was approved by Holly Harvey, Deputy 
Assistant Director for Budget Analysis.

                       FEDERAL MANDATES STATEMENT

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    DUPLICATION OF FEDERAL PROGRAMS

    No provision of H.R. 5214 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program.

                  DISCLOSURE OF DIRECTED RULE MAKINGS

    The Committee estimates that enacting H.R. 5214 would not 
direct specific rule making within the meaning of 5 U.S.C. 551.

                      ADVISORY COMMITTEE STATEMENT

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  APPLICABILITY TO LEGISLATIVE BRANCH

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Recommendations for development and use of clinical data 
        registries

    Section 1 would require the Secretary of HHS to consult 
with clinical experts and make recommendations for the use of 
clinical data registries to improve patient care. Specifically, 
the bill directs the Secretary to include in the 
recommendations: (1) standards to allow exchange of information 
between electronic health records and registries, (2) how 
registries can be used to evaluate models and methods of care, 
(3) how registries can be used to monitor the safety and 
efficacy of products approved by the Food and Drug 
Administration, (4) how registry data can inform health care 
professionals on the prevention of disease and how educational 
resources derived from registry data can be disseminated, and 
(5) how registries can promote preventive health care.

         CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    This legislation does not amend any existing Federal 
statute.

                                  [all]